Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?-Reference-Cited by-同舟云学术

Personalized and longitudinal electronic informed consent in clinical trials: How to move the needle?

Published:2024-01 Issue: Volume:10 Page:
ISSN:2055-2076
Container-title:DIGITAL HEALTH
language:en
Short-container-title:DIGITAL HEALTH

Author:

De Sutter Evelien¹²^ORCID,Barbier Liese¹²^ORCID,Borry Pascal³,Geerts David⁴,Ioannidis John P.A.²⁵⁶,Huys Isabelle¹

Affiliation:

1. Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium

2. Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA

3. Centre for Biomedical Ethics and Law, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium

4. KU Leuven Digital Society Institute, KU Leuven, Leuven, Belgium

5. Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA

6. Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, California, USA

Abstract

Changes in the clinical trials landscape have been driven by advancements in digital technology. The use of electronic informed consent to inform research participants and to obtain their consent electronically has the potential to improve participant–researcher interactions over time, facilitate clinical trial participation, and increase efficiency in clinical trial conduct. A personalized electronic informed consent platform that enables long-term interactions with the research team could function as a tool to empower participant engagement in clinical trials. However, significant challenges persist impeding successful and widespread implementation. This Perspective provides insights into the opportunities and challenges for the implementation of electronic informed consent in clinical trials. It sets out key recommendations to promote the implementation of this innovative approach to the informed consent process, including the creation of uniform electronic informed consent platforms at regional and national level.

Publisher

SAGE Publications

Subject

Health Information Management,Computer Science Applications,Health Informatics,Health Policy

Link

http://journals.sagepub.com/doi/pdf/10.1177/20552076231222361

Reference47 articles.

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